Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint
Approval Still Expected And Differentiation Remains Intact
The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.
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The first Phase III trial testing relugolix combination therapy in endometriosis pain showed efficacy with minimal bone mineral density loss, an issue with AbbVie's rival drug Orilissa. An US NDA was also filed in prostate cancer.
Scrip spoke with Sumitovant CEO Myrtle Potter about short- and long-term goals for the portfolio of five companies, including Myovant, Urovant and Enzyvant with potential near-term approvals.
Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.